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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02799095




Registration number
NCT02799095
Ethics application status
Date submitted
1/06/2016
Date registered
14/06/2016
Date last updated
24/01/2024

Titles & IDs
Public title
A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors
Scientific title
A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1
Secondary ID [1] 0 0
ALK4230-A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALKS 4230
Treatment: Drugs - ALKS 4230 + pembrolizumab

Experimental: ALKS 4230 -

Experimental: ALKS 4230 + pembrolizumab -


Treatment: Drugs: ALKS 4230
Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period

Treatment: Drugs: ALKS 4230 + pembrolizumab
IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterization of adverse events (AEs) and dose-limiting toxicities (DLT) in study Part A
Timepoint [1] 0 0
From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Primary outcome [2] 0 0
Incidence of drug-related AEs in study Part B
Timepoint [2] 0 0
From time of initiation of therapy until 30 days after last dose of study drug, assessed up to 24 months
Primary outcome [3] 0 0
Overall response rate (ORR) of ALKS 4230 monotherapy in patients with melanoma or renal cell carcinoma (Part B) and in combination with pembrolizumab in patients with advanced solid tumors (Part C)
Timepoint [3] 0 0
From time of initiation of therapy until 30 days after last dose of study drug assessed up to 24 months
Secondary outcome [1] 0 0
Disease Control Rate
Timepoint [1] 0 0
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Secondary outcome [2] 0 0
Duration of response in subjects with CR/iCR or PR/iPR
Timepoint [2] 0 0
From time of initiation of therapy until the date of first documented tumor progression, assessed up to 24 months
Secondary outcome [3] 0 0
Serum concentrations of ALKS 4230 will be determined at various time points
Timepoint [3] 0 0
From time of initiation of therapy until the last treatment cycle, assessed up to 24 months
Secondary outcome [4] 0 0
Serum will be assayed for the presence of anti-ALKS 4230 antibodies
Timepoint [4] 0 0
From time of initiation of therapy until the last treatment cycle, assessed up to 24 months
Secondary outcome [5] 0 0
Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry at various time points
Timepoint [5] 0 0
From time of initiation of therapy until the last treatment cycle, assessed up to 24 months
Secondary outcome [6] 0 0
Serum concentrations of proinflammatory cytokines will be assessed using a multiplex method at various time points
Timepoint [6] 0 0
From time of initiation of therapy during the first two treatment cycles, assessed up to 2 months

Eligibility
Key inclusion criteria
- For Part A, the subject has histological or cytological evidence of a solid tumor; for
Part B, the subject has a diagnosis of melanoma or renal cell carcinoma

- All subjects must have advanced solid tumors that have returned after treatment with
established approved therapies or be intolerant of established therapies

- Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as
a target lesion

- Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1, and has an estimated life expectancy of at least 3
months

- Subject must have adequate hematologic reserve

- Subjects must have adequate liver function

- Subjects must have adequate kidney function

- Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy,
other prior systemic anticancer therapy, radiotherapy or surgery

- Subjects who have received investigational agents must wait at least 4 weeks

- Females of childbearing potential must have a negative pregnancy test within 7 days of
the start of treatment and on Day 1 before the first dose is administered. A female
not of childbearing potential is one who has undergone bilateral oophorectomies or who
is postmenopausal, defined as >45 years of age and without a menstrual period for 12
consecutive months

- Meets contraceptive requirements defined in the protocol

- Additional criteria may apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject is currently pregnant or breastfeeding, or is planning to become pregnant
during the study

- Subjects with an active infection or with a fever >/= 38.5 degrees C within 3 days of
the first scheduled day of dosing for Cycle 1

- Subjects with active or symptomatic central nervous system metastases are excluded.
Subjects with central nervous system metastases are eligible for the study if the
metastases have been treated by surgery and/or radiation therapy, the subject is off
corticosteroids for at least 2 weeks and the subject is neurologically stable

- Subjects have a mean QT interval corrected by the Fridericia Correction formula value
of >470 msec (in females) or >450 msec (in males)

- Subjects with known hypersensitivity to any components of ALKS 4230

- Subjects with known hypersensitivity to any components of pembrolizumab (for patients
in combination arm only)

- Subjects who require pharmacologic doses of corticosteroids; replacement doses,
topical, ophthalmologic, and inhalational steroids are permitted

- Subjects who developed autoimmune disorders while on prior immunotherapy, including
pneumonitis, nephritis, and neuropathy

- Subjects with any other concurrent uncontrolled illness, including mental illness or
substance abuse, which may interfere with the ability of the subject to cooperate and
participate in the study

- The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis
B or C, or active tuberculosis, or has a known history of tuberculosis

- Subjects with dyspnea at rest of requiring oxygen therapy

- Subjects active autoimmune disease requiring systemic treatment within the past 30
days

- Subjects who received radiotherapy within the last 4 weeks before start of study
treatment administration with the exception of limited field palliative radiotherapy

- Subjects who have received systemic immunomodulatory agents within 28 days prior to
C1D1.

- Subjects who have received administration of a live, attenuated vaccine within 4 weeks
of Cycle 1, Day1.

- Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow
transplant recipients

- Subjects who have received prior IL-2 based or IL-15 based cytokine therapy

- Additional criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2023
Sample size
Target
Accrual to date
Final
243
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Mural Oncology Investgational Site - Albury
Recruitment hospital [2] 0 0
Mural Oncology Investigational Site - Waratah
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Belgium
State/province [11] 0 0
MO
Country [12] 0 0
Belgium
State/province [12] 0 0
West-Vlaanderen
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Daejeon
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Poland
State/province [18] 0 0
Poznan
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mural Oncology, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To better understand the safety and tolerability of ALKS 4230 in humans
Trial website
https://clinicaltrials.gov/ct2/show/NCT02799095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Mural Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02799095